The purpose of this study is to determine if restoring normal metabolic function in patients with either type I or type II diabetes can improve the impact of the consequences of diabetic complications on the overall quality of life of diabetic patients. Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion. A 44 item questionnaire is completed prior to the start of the treatment and quarterly thereafter with detailed analysis performed to measure progress and outcomes.

Researchers will assess whether pulsatile IV insulin therapy can successfully reverse the abnormal underlying metabolism in diabetic patients to the point of improving their quality of life. [ Time Frame: Patients will complete a quality of life questionnaire prior to the start of treatment and quarterly thereafter to objectively determine if the patients identify quality of life improvement ] [ Designated as safety issue: No ]

Diabetic patients will complete diabetic impact measurement scale questionnaires at baseline and quarterly thereafter in order to determine and track outcomes after the start of pulsatile intravenous insulin therapy.

Procedure: Effects of Pulsatile IV insulin on Diabetic Quality of Life

Patients receive weekly treatments of Pulsatile Intravenous insulin therapy. The patient's Endocrinologist determines the insulin dosage each week based upon the patient's response to treatment and their insulin resistance.

The researchers will include up to 200 patients both male and female between the ages of 21 and 85 diagnosed with type 1 or type 2 diabetes mellitus.

Self reporting or diagnosed with significant complications resulting from diabetes

Taking oral agents and/or insulin for diabetic control

Under an Endocrinologists supervision for their diabetes management. Endocrinologist must assess and approve patient for participation in this study

Ability to swallow without difficulty

Ability to commit to the weekly time requirements associated with the study

Exclusion Criteria:

Other causes of complications not related to diabetes

Inability to respond to 44 item questionnaire

Lack of intravenous access

Pregnancy

Alcohol abuse, drug addiction or the use of illegal drugs

Positive HIV

Inability to breathe into machine for respiratory quotients

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228878